NEW — CLSI EP46
Determining Allowable Total Error Goals and Limits for Quantitative Medical Laboratory Measurement Procedures
CLSI EP46 provides models and approaches for setting allowable total error (ATE) goals and limits, helping developers and laboratories define acceptance criteria for quantitative test methods.
This essential resource covers:
Approaches for determining ATE based on clinical outcomes, biological variation, and state-of-the-art performance.
Considerations across all phases of the measurement procedure.
Practical application of ATE concepts to validation and verification studies.
CLSI EP46 is foundational for any laboratory performing analytical performance studies, and can be used in conjunction with CLSI method evaluation documents such as CLSI EP05, EP06, EP09, and EP21.
NEW — CLSI EP21
Estimation of Total Analytical Error for Clinical Laboratory Measurement Procedures
CLSI EP21 provides study designs and approaches for evaluating total analytical error—critical for verifying that test methods meet established ATE goals and limits.
This document helps:
Developers set appropriate performance acceptance criteria.
Medical laboratories evaluate total analytical error before performing analytical performance studies.
Regulators and accreditors assess whether total analytical error and its components meet defined limits.
CLSI EP21 includes two flexible study approaches designed to accommodate different testing scales and evaluation needs, and aligns closely with the ATE guidance provided in CLSI EP46.
As quality expectations and regulatory scrutiny around total analytical error increase, laboratories and developers need robust, standardized approaches for setting and evaluating error limits. CLSI EP46 and EP21 provide the essential guidance you need to ensure your quantitative measurement procedures are accurate, reliable, and clinically valid.
Access these newly released standards today and strengthen your laboratory’s testing accuracy.
